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EC number: 202-895-5 | CAS number: 100-85-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 Sep 2018 - 24 Oct 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The substance can be produced through different process routes, yielding solutions in water or organic solvent (e.g. methanol or ethylene glycol).
It was initially unclear how to register the substance (mono-constituent or multi-constituent substance) and which manufactured substance to test to fulfil the REACH data requirements. After consultation with the ECHA helpdesk, the test program was started with the manufactured substance of the Lead registrant (solvent: methanol) in which the highest amount of solvent could be removed without causing degradation of the substance. This resulted in the selection of a solution of 56-57% BTMAOH in methanol as test substance.
During the course of the test program, and in order to aid meaningful risk assessment, after consultation with ECHA and upon ECHA's recommendation, it was considered to be more appropriate to test the water-based manufactured substance. As a consequence, some testing was performed with a BTMAOH solution in methanol, and some testing was performed with a BTMAOH solution in water.
The current entry reflects a test performed with a water-based test solution. - Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: all test concentrations and Control
- Sampling method: 2.0 mL at t=0 h, t=24 h and t=96 h.
- Sample storage conditions before analysis: Samples were stored in a freezer (≤-15°C) until analysis at the analytical laboratory of the Test Facility. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- The batch of test item tested was a clear and almost colourless liquid and completely soluble in test medium at the concentrations tested. A correction was made for the water content of the test item. All reported concentrations are based on the pure test item.
- Preparation of test solutions started with the highest concentration of 100 mg/L applying a 15-minute period of magnetic stirring to accelerate dissolution of the test item in test medium. After adjusting the pH from 10 to 7.9 in the limit test, the solution was used as the highest test concentration. All test solutions were clear and colorless at the end of the preparation procedure.
- Controls:
Test medium without test item or other additives - Test organisms (species):
- Cyprinus carpio
- Details on test organisms:
- TEST ORGANISM
- Common name: Carp (Cyprinus carpio, Teleostei, Cyprinidae) Linnaeus, 1758
- Source: Zodiac, proefacc. "De Haar Vissen", Wageningen University and Research Centre, The Netherlands
- Mean length at study initiation: 2.8 +/- 0.2 cm (Limit test)
- Mean weight at study initiation: 0.25 +/- 0.07 g (Limit test)
- Method of breeding: F1 from a single parent-pair bred in UV-treated water
- Total fish used: 26 (Range-Finding study and Final Test)
HOLDING
- Quarantine/Acclimatisation: At least 12 days after delivery
- Medium: Adjusted ISO medium, formulated using tap-water purified by reverse osmosis
- Feeding: Daily with pelleted fish food (Essence (300-500 um), Coppens International bv, Helmond, The Netherlands)
- Validity of batch: In the batch of fish used for the test, mortality during the seven days prior to the start of the test was less than 5%. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 180 mg CaCO3 / L
- Test temperature:
- 20 - 21 °C
- pH:
- Control:
- t=0 h: 7.9
- t=96 h: 7.6
100 mg/L:
- t=0 h: 7.9
- t=96 h: 7.5 - Dissolved oxygen:
- Control:
- t=0 h: 9.1
- t=96 h: 8.0
100 mg/L:
- t=0 h: 9.1
- t=96 h: 8.1 - Nominal and measured concentrations:
- Nominal: 100 mg/L
Measured (mg/L): The measured concentrations were at 96-97% of the nominal concentration throughout the test duration. Based on these results, the nominal exposure concentrations were used to express the effect parameters. See Table 1 in 'Any other information on results' for details on measured concentrations. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 6.5 litres, all-glass, containing 5 litres of test solution
- Test type: static
- Aeration: no aeration
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.58 g fish/L
TEST MEDIUM / WATER PARAMETERS
- Test medium: Adjusted ISO medium
- Culture medium different from test medium: no
- Intervals of water quality measurement: Dissolved oxygen content, pH and temperature were measured daily in all vessels with surviving fish, beginning at the start of the test (day 0).
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h daily
- Feeding: No feeding from 24 hours prior to the test and during the total test period
- Introduction of fish: Within 13 minutes after preparation of the test media from a holding tank with comparable water quality parameters and pH and temperature differences between test and holding tank media of less than 1.0 unit and 1.0°C, respectively.
TERMINAL PROCEDURES
- Euthanasia: At the end of the test, the surviving fish were rapidly killed by exposing them to ca. 1.2% ethylene glycol monophenylether in water.
EFFECT PARAMETERS MEASURED
- Mortality and other effects: At 3.75, 24, 48, 72 and 96 hours following the start of exposure. In addition, every afternoon from day 0 to observe for any dead or severely distressed fish. Dead fish were removed when observed.
TEST CONCENTRATIONS
- Range finding study test concentrations: 0.1, 1.0, 10 and 100 mg/L (3 fish per concentration).
- Results used to determine the conditions for the definitive study: yes; no mortality or clinical effects were observed at any of the test concentrations during the test period, therefore a limit test was performed. - Reference substance (positive control):
- yes
- Remarks:
- Pentachlorophenol (performed March 2018)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: BTMAOH
- Basis for effect:
- mortality (fish)
- Details on results:
- - One fish died in the limit concentration after 24 hours of exposure. No further mortality or clinical effects were recorded during the test period.
- 24h-, 48h-, 72h- and 96h-LC50 were all >100 mg/L
- All environmental parameters remained within the limits as specified in the study plan. - Results with reference substance (positive control):
- - Results with reference substance valid? Yes
- Mortality: 0% at 0.10 mg/L PCP; 100% at 0.22 mg/L PCP (already observed after 24h); 100% at 0.46 mg/L PCP (already observed after 24h)
- LC50: 0.15 mg/L, 95% confidence interval 0.10-0.22 mg/L
- The range of the 96h-LC50 for carp is generally between 0.10 mg/L and 0.46 mg/L based on historical data of reference tests performed by the Test Facility. Hence, the sensitivity of carp originating from the batch used in the reference test for PCP falls within the range of sensitivities generally observed during the past years. - Reported statistics and error estimates:
- No LC50 could be determined because the test item proved to be non-toxic (LC50 > maximum concentration tested).
- Sublethal observations / clinical signs:
Table 1: Limit Test: Test Samples
Time of sampling
[hours]Concentration
[mg/L]Relative to nominal
[%]Relative to initial
[%]Nominal
Analyzed
0
0
n.d.
n.a.
100
96.8
97
24
0
n.d.
n.a.
n.a.
100
96.1
96
99
96
0
n.d.
n.a.
n.a.
100
97.0
97
100
n.d.Not detected.
n.a.Not applicable.
Table 2: Incidence of Mortality and Total Mortality During the Limit Test
Test substance nominal concentration (mg/L)
Initial number of fish
Cumulative mortality
Total mortality (%)
3.75h
24h
48h
72h
96h
Control
7
0
0
0
0
0
0
100
7
0
1
1
1
1
10
- Validity criteria fulfilled:
- yes
- Remarks:
- See 'Overall remarks' for details on validity criteria.
- Conclusions:
- The 96h-LC50 was beyond the range tested, i.e. exceeded the analytically confirmed nominal concentration of 100 mg/L (corrected for water content).
- Executive summary:
In a study performed in accordance with OECD 203 (1992) and according to GLP principles, the acute toxicity of the substance to carp (Cyprinus carpio) was investigated. In a static test, carp were exposed for 96 hours to an untreated control and a nominal concentration of 100 mg/L (corrected for water content, 7 fish per treatment group). A correction was made for the water content of the substance, i.e. all reported concentrations are based on the pure test substance.
Measured concentrations were 96 -97% of the nominal concentration throughout the test duration. Based on these results, the nominal exposure concentrations were used to express the effect parameter.
One fish died in the limit concentration after 24 h of exposure. No further mortality or clinical effects were recorded during the test period.
The 96h-LC50 of the substance to carp is concluded to be beyond the range tested, i.e. exceeded the analytically confirmed nominal concentration of 100 mg/L (based on the pure test item, corrected for water content).
The test met all validity criteria and is considered to be reliable without restriction.
Reference
Description of key information
The 96h-LC50 was beyond the range tested, i.e. exceeded the analytically confirmed nominal concentration of 100 mg/L (based on BTMAOH); 96h-LC50: > 100 mg/L.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 100 mg/L
Additional information
In a study performed in accordance with OECD 203 (1992) and according to GLP principles, the acute toxicity of the substance to carp (Cyprinus carpio) was investigated. In a static test, carp were exposed for 96 hours to an untreated control and a nominal concentration of 100 mg/L (7 fish per treatment group). A correction was made for the water content of the test item, i.e. all reported concentrations are based on BTMAOH.
Measured concentrations were 96 -97% of the nominal concentration throughout the test duration. Based on these results, the nominal exposure concentrations were used to express the effect parameter.
One fish died in the limit concentration after 24 h of exposure. No further mortality or clinical effects were recorded during the test period.
The 96h-LC50 of the substance to carp is concluded to be beyond the range tested, i.e. exceeded the analytically confirmed nominal concentration of 100 mg/L.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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